ANDA 219973, held by Shuangcheng. Pantoprazole Sodium.
As of Nov 15, 2026, ANDA 219973 (Pantoprazole Sodium), held by Shuangcheng, was first approved by FDA on Apr 22, 2026, with 0 approved supplements and 0 published complete response letters.
Pantoprazole Sodium for Injection is indicated for treatment of: gastroesophageal reflux disease (GERD) and a history of erosive esophagitis (EE) for up to 10 days in adults. pathological hypersecretory conditions including Zollinger-Ellison (ZE) Syndrome in adults.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Apr 22, 2026 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Pantoprazole SodiumEQ 40MG BASE/VIAL · injectable;intravenous | Pantoprazole Sodium | Rx |
Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters
